Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
QRR is the FDA product code for Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside, a class II device type, regulated under 21 CFR 888.3046. FDA's definition for this code reads: "A resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial is a resorbable implant intended to fill bony defects of the extremities where there is an increased risk of infection. It is intended to resorb over time and be replaced by new bone. The product is intended for...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QRR
- Device name
- Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
- FDA definition
- A resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial is a resorbable implant intended to fill bony defects of the extremities where there is an increased risk of infection. It is intended to resorb over time and be replaced by new bone. The product is intended for reduction of recurrence of chronic osteomyelitis of long bones. It is not intended to treat infection.
- Regulation
- 21 CFR 888.3046
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code QRR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code QRR| Applicant | Clearances |
|---|---|
| Bonesupport Inc | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.